Gene ruling has far reaching implications

The U.S. Supreme Court's recent unanimous decision that human genes cannot be patented has the potential to be a game-changer for the medical and biotechnology industries in the United States.

Patient advocates are hailing the ruling as a boon to health care consumers, while others predict a chilling effect on the medical and biotechnology industries.

It remains to be seen whether the indirect effects of the ruling will be good or bad for the industries and for patients awaiting a breakthrough treatment.

The decision was based on existing patent law, which says that the laws of nature, natural phenomena and abstract ideas are not patentable, according to an Associated Press article.

That means no one can hold a patent on gold, for instance, or clouds or a naturally occurring part of the human body, however small.

That's because patents are held by individuals or companies that invent something - and none of those things were invented.

Writing for the court, Justice Clarence Thomas said of the defendant in the case, Myriad, Inc., "Myriad did not create anything." He went on to say that naturally occurring DNA segments are not eligible for patent "merely because it has been isolated."

But the court was not inflexible. It also ruled that synthetically-created DNA, called cDNA, is eligible for patent, according to an article in USA Today.

That seems reasonable.

Jeremy Gruber, an attorney and executive director of the Council for Responsible Genetics, an advocacy group based in New York, called the ruling "a commonsense decison" in a telephone interview Thursday with The Daily Advertiser.

The original lawsuit was filed by the ACLU's Women's Rights Project against Salt Lake City-based Myriad, Inc. over its patenting of the BRCA1 and BRCA2 genes. The BRCA gene was used to develop the BRCAnalysis test, which seeks out mutations on the gene, which can predict the risk of breast and ovarian cancer.

While some within the industry have reportedly predicted that the loss of exclusive rights to genes might take away the financial incentive for companies to develop new tests and cures, patient advocates and others say it will make tests and treatments more affordable and more accessible.

Myriad had a "monopoly on testing" for breast and ovarian cancer genes, Gruber said, which kept the cost of the tests high. Competition will bring them down.

Gruber's theory is already being borne out by a Houston-based company that is offering the test for less than $1,000, about one-fourth of what Myriad was charging.

That is great news for those with a possible predisposition to breast or ovarian cancer who may want to take preventive measures.

The ruling will also have far-reaching effects retroactively. It has reversed human gene patents that have been awarded over the past 30 years by the U.S. Patent and Trademark Office.

This will throw the field open to companies other than those that held the patents, Gruber said. And that increases the possibility that one of them may find medical breakthroughs.

There are also larger issues to consider, when it comes to ownership of human genes.

The scientific community stands on the threshold of biotechnology that most may not even be able to envision yet.

As Gruber puts it, "The future is here," and in the world of medical research, "fantasy is moving toward reality."

Advances in cloning and stem cell research are advancing rapidly, Gruber pointed out.

In the near future, the nation will be grappling with more ownership issues.

The Supreme Court decision does not end the discussion, but, if anything,begins the discussion, Gruber said.

And that is why the Supreme Court's decision to uphold the principle that no part of a human being may be owned is vitally important.

It may come to bear in the not-so-distant future in situations we are not able to even dream of - not yet.

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Gene ruling has far reaching implications

The U.S. Supreme Court's recent unanimous decision that human genes cannot be patented has the potential to be a game-changer for the medical and biotechnology industries in the United States.